Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hangzhou AllTest Biotech with 14 510(k) clearances. The most recent is a 510(k) clearance dated Apr 30, 2026: AllTest Strep A Rapid Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 30, 2026 | AllTest Strep A Rapid TestK260342 · GTY | 510(k) clearances |
| Oct 30, 2025 | AllTest Urinary Tract Infection TestK252607 · JMT | 510(k) clearances |
| Jul 15, 2025 | Shinetell PlusTM Digital Early Pregnancy TestK251053 · LCX | 510(k) clearances |
| Apr 4, 2025 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK250727 · NFT | 510(k) clearances |
| Apr 4, 2025 | AllTest Viral Transport MediumK242576 · JSM | 510(k) clearances |
| Feb 27, 2025 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupK244043 · NFT | 510(k) clearances |
| Sep 27, 2024 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelK242540 · NFT | 510(k) clearances |
| Aug 13, 2024 | Shinetell Digital Pregnancy TestK241978 · LCX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
